Shots: The P-III APSEN study involve assessing of Brukinsa (zanubrutinib) vs AbbVie’s Imbruvica (ibrutinib) in 229 patients with r/r or TN WM across 61 centers in the US, EU and Australia The P-III APSEN study resulted in not meeting its 1EPs, i.e, superiority in CR & VGPR rate in up to 3yrs.; in r/r patients […]Read More
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year’s record of approvals. However, there is a significant […]Read More
Shots: The US FDA’s accelerated approval is based on P-II BGB-3111-206 and P-I/II BGB-3111-AU-003 studies assessing Brukinsa in patients with relapsed or refractory (R/R) MCL The P-II BGB-3111-206 & P-I/II BGB-3111-AU-003 studies result: ORR (84% & 84%); CR (59% & 22%, FDG-PET scan required & not required); PR (24% & 62%); DOR (19.5 & 18.5 […]Read More
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